The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Angiopro Release 2.1.
Device ID | K933791 |
510k Number | K933791 |
Device Name: | PHILIPS ANGIOPRO RELEASE 2.1 |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Contact | William G Mcmahon |
Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-04 |
Decision Date | 1993-11-22 |